BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE FORTIFY 20MM CORE, HEIGHT 41-64MM

    MDR report key: 4613246 · Received March 13, 2015

    Report

    Report Number
    3004142400-2015-00010
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS NO LOT NUMBER WAS PROVIDED. NO EVALUATION COULD BE PERFORMED AS THE IMPLANT WAS NOT REMOVED FROM THE PATIENT. IT WAS REPORTED THAT DURING THE REVISION SURGERY THE IMPLANT COULD NO BE REMOVE, BECAUSE THERE WAS BONE GRAFT MATERIAL IN AND AROUND THE CAGE WHICH MADE MOBILIZING IT DIFFICULT. IN ADDITION, ACCESS TO THE SURGICAL SITE WAS LIMITED AS THE PROCEDURE WAS DONE THROUGH A RETRACTOR WITH NARROW OPENING. AS A RESULT, THE IMPLANT WAS RE-EXPANDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GLOBUS THAT A PATIENT WAS COMPLAINING OF BACK PAIN. A CT SCAN REVEALED FORTIFY CORE LOST ITS INITIAL HEIGHT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174659 DEVICE FORTIFY 20MM CORE, HEIGHT 41-64MM FORTIFY 20MM CORE, NKB GLOBUS MEDICAL, INC. 151.153

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention